Revolution cf/ctDNA Fully Automated Sample Preparation System

Overview

The Revolution cf/ctDNA Fully Automated Sample Preparation System is an integrated, walk-away platform engineered for high-fidelity isolation and purification of cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA) from plasma, serum, and other low-volume biofluids. Leveraging magnetic bead-based solid-phase extraction chemistry under precisely controlled fluidic actuation and thermal management, the system automates all critical steps—including plasma separation (when coupled with compatible centrifugation modules), nucleic acid binding, washing, elution, and optional post-purification quantification integration. Designed specifically for oncology liquid biopsy workflows, it minimizes manual intervention while maintaining stringent recovery efficiency (>85% for 10–1000 bp fragments) and reproducibility (CV < 8% across runs), supporting downstream applications such as digital PCR, next-generation sequencing (NGS), and methylation profiling.

Key Features

• Fully automated end-to-end workflow—from raw blood collection tubes to eluted cf/ctDNA in ≤3.5 hours, accommodating up to 24 samples per run.
• Integrated sample tracking via 2D barcode scanning of tube labels and reagent kits, ensuring full traceability compliant with ISO 15189 and CLIA requirements.
• Onboard real-time monitoring of critical process parameters: magnetic bead dispersion homogeneity, wash buffer temperature stability (±0.5 °C), and elution volume accuracy (±2 µL).
• Modular architecture supporting seamless integration with pre-analytical automation (e.g., automated plasma aliquoting) and downstream NGS library prep systems via standard API interfaces (RESTful JSON).
• Dedicated contamination control: HEPA-filtered laminar airflow enclosure, UV-C sterilization cycle between runs, and disposable fluid path cartridges certified DNase/RNase-free per ISO 11137.

Sample Compatibility & Compliance

The system processes K₂EDTA, Streck, PAXgene, and Roche Cell-Free DNA BCT blood collection tubes—validated per manufacturer specifications. Plasma input volumes range from 1–5 mL, with optimized protocols for fragmented DNA preservation and inhibitor removal. All consumables meet USP endotoxin limits (<0.5 EU/mL) and are supplied with CoA and CoC documentation. The platform supports 21 CFR Part 11-compliant user access control, electronic signatures, and audit trail generation for GLP/GCP/GMP-aligned laboratories. Method validation reports—including precision, accuracy, limit of detection (LoD), and carryover assessment—are provided upon installation qualification.

Software & Data Management

Controlled by RevolutionLink™ v4.2 software, the system features a validated Windows-based interface with role-based permissions (Administrator, Technician, Reviewer). Workflow configuration is managed through protocol templates editable only by authorized users; changes trigger automatic versioning and change logs. Raw instrument data (including sensor logs, timing stamps, and error codes) are stored locally in encrypted SQLite databases and exportable in CSV or XML formats compatible with LIMS (e.g., LabVantage, STARLIMS). Audit trails record all user actions, parameter modifications, and system events with immutable timestamps—retained for ≥10 years per internal data retention policy and aligned with FDA expectations for analytical instrument records.

Applications

• Minimal residual disease (MRD) monitoring in hematologic malignancies using ultra-sensitive ctDNA assays.
• Early cancer detection research requiring consistent, low-input cfDNA yield and fragment size distribution integrity.
• Clinical trial biomarker analysis where inter-laboratory reproducibility and regulatory documentation are mandatory.
• Reference laboratory scale-up of liquid biopsy testing without proportional increases in hands-on technician time.
• Method transfer and harmonization across multi-site diagnostic networks operating under CAP/CLIA accreditation frameworks.

FAQ

Does the Revolution cf/ctDNA system support custom protocol development?
Yes—advanced users may define new extraction protocols using the built-in script editor, subject to validation and administrator approval.
Is the system compatible with third-party quantification modules such as Qubit or Bioanalyzer?
It includes optional USB- and I²C-enabled interfaces for direct communication with select fluorometers and capillary electrophoresis instruments.
What is the recommended maintenance schedule?
Daily cleaning cycles, monthly calibration of pipetting accuracy (±1.5% at 20 µL), and annual preventive maintenance by certified field service engineers.
Can the system be operated in a cleanroom environment (ISO Class 7)?
Yes—the footprint (72 cm × 65 cm × 60 cm) and EMI-shielded design meet ISO 14644-1 requirements when installed with appropriate HVAC integration.
Are reagents and consumables supplied exclusively through the distributor network?
All magnetic bead kits, wash buffers, and cartridge sets are manufactured under ISO 13485 and distributed only through authorized channels to ensure lot-level consistency and regulatory traceability.